BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S500 by TUNG KENG ENTERPRISE CO., LTD.

The Be-Mobile 4-Wheeled Electric Scooter DK S500 is an indoor / outdoor electric scooter that is battery operated. It has a base with four-wheeled with a seat. The movement of the scooter is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.

AI/ML Overview

The provided text is a 510(k) summary for the Be-Mobile 4-Wheeled Electric Scooter, DK S500. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance criteria through a detailed clinical study.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not present in the provided document.

Here's why and what information is available:

1. A table of acceptance criteria and the reported device performance:

Not Applicable. The document does not describe specific performance-based acceptance criteria for the scooter in terms of clinical outcomes or diagnostic accuracy. Instead, it relies on demonstrating that the new device meets established safety and performance standards and is substantially equivalent to a legally marketed predicate device.
Reported Device Performance (from the document): The document states:
- "The electronic systems between two devices are the same and all passed by the UL certificated, for instance the electronic controller, batteries and recharge. Thus the same safety level for the two devices is assured."
- The device underwent "Performance Testing" to standards: ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 (Electrically powered wheelchairs, scooters, and their chargers - requirements and test methods).

2. Sample size used for the test set and the data provenance:

Not Applicable. No test set or clinical data is described in terms of a sample size. The "performance testing" referred to are likely engineering and safety tests on the device itself, not a study involving human subjects or clinical data in the way implied by the question.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. As no clinical "test set" relying on a ground truth is described, there's no mention of experts or their qualifications in this context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not Applicable. No adjudication method is described as there is no clinical test set requiring such a process.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not Applicable. An MRMC study is completely irrelevant to this device (an electric scooter). The device does not involve "readers" or "AI assistance."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not Applicable. This device is an electric scooter, it does not involve an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not Applicable. Ground truth in the context of clinical or diagnostic performance assessment is not relevant for this device. The "truth" here relates to compliance with engineering standards and safe operation, as demonstrated by the listed performance tests.

8. The sample size for the training set:

Not Applicable. This device (an electric scooter) does not involve machine learning algorithms that would require a "training set."

9. How the ground truth for the training set was established:

Not Applicable. See point 8.

Summary of what the document DOES tell us about the device's validation:

Mechanism of Validation: The primary validation method for this 510(k) submission is demonstrating substantial equivalence to a previously legally marketed device (WU'S 4-WHEELED NEO SCOOTER WT-L4, K013763).
Key Differences and Justification: The main differences identified are the type of electronic controller, overall dimensions, tire size, and weight. The submitter argues that the different controller (Dynamic Rhino DS72k vs. Curtis PMC) and physical appearance differences are not safety aspects and therefore do not negate substantial equivalence.
Safety Assurance: The document emphasizes that the "electronic systems between two devices are the same and all passed by the UL certificated," ensuring the same safety level.
Performance Standards: The device was tested against recognized industry standards for electrically powered wheelchairs, scooters, and their chargers (listed in section 1 above).

Summary

{0}------------------------------------------------

NOV 1 2 2003

TUNG KENG ENTERPRISE CO., LTI No. 1. Lane 160. Sec. 2 Tan-Fu RD., Tan-Tzu Hsiang Taichung County, Taiwan Tel: +886-4-25321000 Fax: +886-4-25325000 E-mail: dkcity@ms21.hinte.net

510(k) SUMMARY " ここ

Submitter's Name: TUNG KENG Enterprise Co., Ltd. No. 1, Lane 160, Sec. 2 Tan-Fu RD., Tan-Tzu Hsiang Taichung County, 427,Taiwan

Date summary prepared:

September 29, 2003

Device Name:

Be-Mobile 4-Wheeled Electric Scooter, DK S500 Proprietary Name: Common or Usual Name: Electrical Scooter Classification Name: Motor Three-Wheeled Vehicle, Class II, 21 CFR 890.3800

Indications for Use:

The device is intended for medical purposes to provide mobility to persons restricted to a seated position.

Description of the device:

Performance Testing:

EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 (Electrically powered wheelchairs, scooters, and their chargers - requirements and test methods)

Legally marketed device for substantial equivalence comparison: WU'S 4-WHEELED NEO SCOOTER WT-L4 (K013763)

{1}------------------------------------------------

K6332 TUNG KENG ENTERPRISE CO., LID. No. 1, Lane 160, Sec. 2 Tan-Fu RD., Tan-Tzu Hsiang Taichung County, Taiwan Tel: +886-4-25321000 Fax: +886-4-25325000 E-mail: dkcity@ms21.hinte.net

2/2

Summary for substantial equivalence comparison:

The electronic systems between two devices are the same and all passed by the UL certificated, for instance the electronic controller, batteries and recharge. Thus the same safety level for the two devices is assured. The major differences existing of the two 4-wheelled scooters are the different controller. That means the new device, DK S500, use Dynamic Rhino DS72k controller, and the predicate device, WT-L4, use Curtis PMC controller. Besides the overall dimension, the size of tires, and the weight are differences between the two devices. The overall appearance differences are not safety aspect. So the new device is substantially equivalent to the predicate devices in this aspect.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

NOV 1 2 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Tung Keng Enterprise Co., Ltd. C/o Dr. Ke-Min Jen ROC Chinese-European Industrial Research Society No. 58, Fu-Chiun St. Hsin-Chu City, China (Taiwan) 300

Re: K033239

Trade/Device Name: Be-Mobile 4 Wheeled Electric Scooter, DK S500 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: September 29, 2003 Received: October 6, 2003

Dear Dr. Jen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

Page 2 - Dr. Ke-Min Jen

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

miriam C. Provost

for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Page_1 Of

510 (K) NUMBER ( IF KNOW ): TBA

DEVICE NAME: Be-Mobile 4-Wheeled Electric Scooter, DK S500

INDICATIONS FOR USE:

The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.

( PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE

Concurrence of CDRH, office of Device Evaluation (ODE )

Prescription Use _______________ OR Over - The - Counter - Use V

( Per 21 CFR 801.109 )

( Optional Format 1-2-96 )

n of General, Restor and Neurological Dovi

510(k) Number_

Regulation Number and Section

§ 890.3800 Motorized three-wheeled vehicle.

(a)
Identification. A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.(b)
Classification. Class II (performance standards).